APHA Welcomes SAHPRA's Historic Approval of Lenacapavir: A Watershed Moment for HIV Prevention in South Africa

October 27, 2025

The twice-yearly injectable offers an unprecedented opportunity to accelerate progress toward ending the AIDS epidemic, but urgent demand creation efforts are essential for success

Advocates for the Prevention of HIV in Africa (APHA) applauds the South African Health Products Regulatory Authority (SAHPRA) for approving lenacapavir for HIV prevention. This milestone positions South Africa as a global leader in HIV prevention innovation and brings us significantly closer to ending the AIDS epidemic that has devastated our communities for over four decades.

A Game-Changing Prevention Tool

Lenacapavir represents a remarkable and revolutionary advancement in HIV prevention technology. Unlike daily oral pre-exposure prophylaxis (PrEP), which requires strict daily adherence, lenacapavir is administered subcutaneously just twice a year. Clinical trials have demonstrated its remarkable efficacy, with 100% protection among cisgender women in the PURPOSE-1 trial and 96% protection among men who have sex with men, transgender women, and gender-diverse individuals in the PURPOSE-2 trial[yR1] .

For South Africa, where approximately 8 million people live with HIV and an estimated 149,000 new infections occurred in 2023, this innovation addresses critical barriers that have limited the impact of existing prevention methods. The convenience of twice-yearly dosing, combined with its discretion and superior adherence profile, makes lenacapavir particularly valuable for adolescent girls and young women, who account for four out of every ten new infections despite comprising only 8% of the population.

"SAHPRA's approval of lenacapavir is a historic moment for HIV prevention in South Africa," said Yvette Raphael, Executive Director of APHA. "This twice-yearly injectable has the potential to transform our HIV prevention landscape. However, we must be clear: scientific innovation alone will not end HIV. The real work begins now through ensuring that every person who could benefit from lenacapavir knows about it, can access it, and chooses to use it."

"With groundbreaking options like Lenacapavir bolstering HIV prevention efforts, we have a renewed sense of urgency to act. All stakeholders must collaborate effectively to strengthen health systems and ensure equitable access to these life-changing tools for everyone who needs them, ultimately turning the tide against new HIV infections." Ntando Yola, APHA co-founder.

Phase 1 Implementation: Ambitious but Constrained

According to the National Department of Health, South Africa's Phase 1 lenacapavir rollout will proceed as follows:

•      Timeline: February/April 2026 to March 2028

•      Target initiations: 456,360 people over two years (912,000 doses)

•      Funding: Approximately USD $29 million (R502 million) from the Global Fund, redirected from the existing Grant Cycle 7 allocation

•      Distribution sites: 360 facilities across 22 priority districts in six provinces:

• Gauteng: 133 sites

• KwaZulu-Natal: 94 sites

• Eastern Cape: 49 sites

• Mpumalanga: 31 sites

• North West: 31 sites

• Western Cape: 22 sites

  
  

While APHA celebrates this initial rollout, we acknowledge that 456,360 initiations over two years falls dramatically short of the 2-4 million annual users that mathematical modelling suggests would be necessary to achieve epidemic control by 2032.

The Critical Challenge: From Approval to Impact

APHA's greatest concern is not regulatory approval or commodity availability, it is demand creation and uptake. South Africa's oral PrEP experience provides a sobering lesson: despite achieving over 2 million PrEP initiations since 2016, and this being the world's largest programme, new HIV infections remain stubbornly high. Recent data shows PrEP initiations declining significantly in some provinces, with the Western Cape experiencing 32-50% drops in the first quarter of 2025 compared to the same period in 2024.

This pattern reveals a fundamental truth that prevention tools only work when people know about them, want them, and use them consistently. Without aggressive, sustained, community-driven demand creation, lenacapavir risks becoming another underutilized innovation that was effective in clinical trials but fails to achieve its population-level potential.

In South Africa potential key barriers to lenacapavir uptake include:

• Most people at risk of HIV acquisition do not yet know lenacapavir exists or understand its advantages

• Misconceptions and concerns about injectable medications, side effects, or safety, which require proactive education

• Access barriers and geographic limitations during Phase 1, with only 360 of South Africa's 3,849 primary healthcare facilities targeted to offer lenacapavir

• Persistent HIV-related stigma prevents many people from seeking prevention services

• Facilities must be prepared to counsel clients, administer injections safely, manage adverse events, and track follow-ups, which requires optimal health system capacity.

"We cannot simply wait for people to show up at clinics asking for lenacapavir," emphasized Yvette Raphael. "We must go to the communities, engage peer educators, partner with youth organizations, mobilize faith leaders, work with taxi associations, and leverage every communication platform available. Demand creation is not a peripheral activity, it is the central determinant of whether lenacapavir will save lives or sit unused in refrigerators."

APHA's Commitment: A Strategic Roadmap for Demand Creation

As South Africa's leading community-based HIV prevention advocacy organization, APHA recognizes that lenacapavir's success depends entirely on robust demand creation. Based on our extensive experience in HIV prevention programming and community mobilization, APHA commits to playing a major role in ensuring that every available dose reaches the people who need it most. We propose the following strategic approach and pledge our full organizational capacity to its implementation:

1. Provincial Preparedness and Stakeholder Engagement

APHA proposes to convene multi-stakeholder provincial preparedness workshops across all six Phase 1 provinces, bringing together provincial health departments, district managers, facility staff, community health workers, traditional leaders, youth organizations, women's groups, and key population networks. These convenings will establish coordination mechanisms, clarify roles and responsibilities, address implementation challenges, and ensure that health system readiness goes hand-in-hand with community readiness. APHA is well-positioned to lead this work, building on our established relationships with provincial health departments and civil society networks.

2. Community Champion Mobilization

APHA recommends the deployment of Community Champions, trusted community members with lived HIV experience, who will serve as the bridge between health facilities and communities. These Champions should be trained to conduct peer education, facilitate community dialogues, address misconceptions, provide navigation support, and generate demand at the grassroots level. APHA commits to recruiting, training, and supporting Community Champions in support of Phase 1 implementation at sites and in surrounding communities, ensuring culturally appropriate, community-led engagement.

3. Multi-Channel Communication Campaign

APHA proposes the implementation of a comprehensive, multi-channel awareness campaign in partnership with media outlets, civil society organizations, youth movements, and women's groups. This campaign should utilize social media platforms, community radio broadcasts, SMS messaging, community meetings, peer educator networks, school and campus outreach, workplace programs, and direct healthcare worker engagement. APHA is prepared to serve as the central coordinating hub for these communication efforts, leveraging our extensive networks and communication expertise to ensure consistent, accurate, and compelling messaging.

4. Priority Population Engagement

APHA recommends targeted engagement strategies for populations bearing the highest HIV burden and experiencing the greatest barriers to prevention access. We advocate for the development of population-specific approaches for:

• Adolescent girls and young women (15-24 years) who experience the highest HIV incidence rates and require age-appropriate, empowerment-focused engagement

• Pregnant and breastfeeding women who face heightened HIV acquisition risk and would benefit from integration with maternal health services

• Men who have sex with men who experience a disproportionate HIV burden and require stigma-free, affirming services

• Female sex workers who face high HIV risk and would benefit from discreet, long-acting prevention delivered through trusted channels

• Transgender individuals who experience multiple intersecting barriers to prevention access and require gender-affirming care environments

APHA acknowledges the importance and urgency in this specific lenacapavir demand creation work. We bring decades of community mobilization experience, established relationships with priority populations, and a proven track record in HIV prevention programming. We are ready to mobilize immediately and commit our full organizational resources to making the lenacapavir rollout a success.

Urgent Call to Action

The Global Fund's investment of USD $29 million for 456,360 lenacapavir initiations represents an extraordinary opportunity, but only if we ensure robust demand creation. With limited doses available during Phase 1, every unused dose represents a missed opportunity to prevent HIV infection.

The window for action is narrow, APHA calls on all stakeholders to move with urgency and purpose:

• National and Provincial Health Departments must allocate dedicated resources for demand creation activities; ensure adequate budget for community mobilization, training materials, and communication campaigns

• District Health Managers must prioritize facility readiness, staff training, and community engagement; establish referral networks and support structures

• Healthcare Workers must proactively offer lenacapavir to eligible clients; provide accurate information and address concerns with empathy

• Civil Society Organizations must partner in community mobilization efforts; leverage your networks to spread awareness and address stigma

• Funders and Development Partners must invest in demand creation; recognize that community mobilization is as critical as commodity procurement

• Media Partners must help us reach every community with accurate, accessible information about lenacapavir

"The approval of lenacapavir is not the finish line, it is the starting Gun. Now we must run this race together, with urgency, with coordination, and with unwavering commitment to ensuring that every person who could benefit from this revolutionary prevention tool knows about it and can access it. The next two years will determine whether lenacapavir becomes a game-changer or a missed opportunity. APHA is ready to do our part. We call on everyone else to do theirs." Yvette Raphael

“ The approval of Lenacapavir by the South African health government is such an important and welcome milestone in the ongoing fight for an HIV/AIDS free generation. As advocates, we’ve long highlighted the need for a basket of prevention options and choices, because there’s no one-size-fits-all approach when it comes to prevention. After all, we all lead different lifestyles. This approval is proof that our voices are being heard and are reaching the right people.

But of course, the work doesn’t stop here. We need a collective effort to continue pushing for easy access to this product for young people and to break down the structural barriers that prevent access.

May we continue to show up and speak up. “ Oyama Eland APHA Champion

“Here, I witnessed confidence strengthened. This decision showcases SAHPRA’s capacity to fast-track essential health innovations while maintaining high standards of safety, efficacy, and quality, reinforcing public trust in the national health regulatory system.” Mzwakhe Vilane APHA Force on the Ground

“I extend my heartfelt appreciation to all the dedicated researchers, scientists, and trial participants who made the breakthrough of Lenacapavir possible. Your hard work, innovation, and commitment to ending HIV have brought new hope to millions. A special thank you goes to SAHPRA for its leadership and diligence in ensuring that this life-changing prevention option meets the highest safety and quality standards. This milestone marks not just scientific progress, but a future where every young person, woman, and community member has access to stronger, longer-acting HIV prevention tools. Together, we move closer to an HIV-free generation.”  Dolly

About APHA

Advocates for the Prevention of HIV in Africa (APHA) is a leading community-based organization working across Southern Africa and Africa to advance HIV prevention, expand access to prevention technologies, and mobilize communities to end the AIDS epidemic. Through community engagement, advocacy, research, and implementation support, APHA bridges the gap between scientific innovation and community impact.

Media Contact

Yvette Raphael

Executive Director, APHA

Email: admin@apha.org.za

Tel: +27 76 612 7704

ENDS